A Phase 3 interventional study of Acoziborole in Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense, sponsored by Institute of Tropical Medicine, Belgium. Recruiting at 1 site in Democratic Republic of the Congo. Open to participants aged 11 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Institute of Tropical Medicine, Belgium · Phase 3, Interventional, and Treatment
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.
We hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, we will be able to arrive at a zero prevalence over a three-year period.
The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative.
Recently acoziborole, a non-toxic single dose oral drug for gHAT, has passed phase 3 evaluation in adult patients. This drug is envisioned to be used to treat gHAT irrespective of disease stage, thus rendering the lumbar puncture for stage determination redundant. Having available a single dose oral treatment with limited risk of toxicity opens up new perspectives for eliminating the disease. Treating anyone testing positive to a serological screening test, without further need for on the spot parasitological confirmation and stage determination, will greatly simplify procedures in the field, avoid missing many cases, has the potential to increase uptake of screening and may thus even curb transmission of the causative parasite, which is assumed to have only a human reservoir.
Although this innovative option for gHAT control is now feasible, its true effectiveness and cost effectiveness for curtailing transmission remain to be determined.
The current gHAT control strategy is based on active screening of people living in villages at risk for gHAT by mobile screening teams. All villages from which gHAT cases were reported are screened for three years in a row until no further cases are found. They are then screened once more, two years after the last case was reported. If no further cases are found, transmission is assumed to have been interrupted. This strategy has had a major impact as can be seen from figure 2 above. However, Robays et al. estimated that up to 50% of prevalent cases are not detected or not cured, with major losses occurring during the parasitological confirmation step.[9] Other important barriers are the fear of the lumbar puncture required for stage determination and of toxicity of treatment, in particular associated with melarsoprol, no longer in use for gHAT, but still well-known especially by the elder population. Even if up to 50% of prevalent gHAT cases were not treated, the epidemiological data shows that the disease is on the decline. This may however be insufficient to achieve complete elimination of transmission. We hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, we will be able to arrive at a zero prevalence over a three-year period. Bearing in mind that acoziborole has not yet been registered and that 'screen \& treat' has not yet been adopted as the new policy, we will for the duration of this study continue performing parasitological confirmation on the spot and treat anyone confirmed by parasitology with standard of care. Any serological suspect not confirmed by parasitology on the spot will be offered treatment with acoziborole (study Part B), conditional on a set of inclusion and exclusion criteria If acoziborole allows us to implement a screen \& treat strategy, allowing to detect and treat all g-HAT prevalent cases, and possibly in the future without the limitations of cumbersome diagnostic confirmation on the spot, we expect that elimination of transmission is also possible in a mainland focus. Implementing such a study under relatively well controlled conditions will also allow us to gather further evidence on safety of acoziborole, before a screen \& treat strategy is rolled out on a larger scale. In addition it will provide information on the cost of such a strategy and on some essential parameters of the tests utilized.
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Exclusion Criteria:
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Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The investigational product (IP) is: * acoziborole three 320-mg tablets (960 mg dose), administered by the oral route to adolescent and adults ≥15 years as single dosing regimen on Day 1 of the study in fed or fasting state * acoziborole two 320-mg tablets (640 mg dose), administered by the oral route to children 11-14 years (and ≥30kg) as single dosing regimen on Day 1 of the study in fed or fasting state No active comparative treatment will be used in this study Doses and treatment regimens * Adolescent and adults ≥15 years: 960 mg (3x320mg) oral unique dose in fed or fasting state * Children 11-14 years (and ≥30kg): 640 mg (2x320mg) oral unique dose in fed or fasting state
Drug: Acoziborole
treatment of seropositive individuals (positive serology test, but parasitology not confirmed). Subjects agreeing to participate study and matching the inclusion/exclusion criteria will receive acoziborole 960 or 640 mg in a single intake at study day 1. Following treatment, participants will attend follow-up visits at home or at the study centre at 3 days and 3-months post-treatment.
interruption of transmission of T.b. gambiense
\- To evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b. gambiense in a mainland focus. The number of parasitologically negative seropositive gHAT suspects is reduced to zero or near zero within the timeframe of the project
Time frame: 4 years
Assessment of Safety
To assess the safety of acoziborole in gHAT seropositive individuals and parasitologically-negative by measuring the proportion of participants who present related treatment emergent severe adverse events. Mild, moderate and severe related ermergent adverse events will be measured.
Time frame: 3 year
economic evaluation
Cost data will be gathered throughout the study and used to perform an economic evaluation of the screen \& treat strategy. Recurrent and capital costs of the screen \& treat strategy will be considered.
Time frame: 4 years
assessment of the performance of several diagnostic tests
\- Prospective assessment of specificity and positive predictive value of the screening tests used in the field, CATT and RDT, and of the referral laboratory tests, ELISA/T.b. gambiense, immune trypanolysis and Trypanozoon-RT-PCR multiplex. If a functional inhibition ELISA and a T.b. gambiense specific qPCR become available during STROGHAT, their specificity will be determined retrospectively on the collected study specimens. For the specificity evaluation parasitology will be used as reference test. The specificity will be calculated by measuring the number of index tests negatives over the number of index test negatives plus intex test positives testing negative with the reference test. The reference standard will be parasitological confirmation.
Time frame: 4 years
Plan to share: No — anonymity of participants must be guaranteed, GDRPR rules will apply anonymised study results can be shared with other researchers upon request
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Studies of the drug tested here: SCYX 7158
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